A Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using Mobile EECs (G204)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02582073|
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Biological: Placebo (0.5ml) Biological: Placebo (1.0ml) Biological: Grass MATA MPL (0.5ml) 5100SU Biological: Grass MATA MPL (1.0ml) 10200SU Biological: Grass MATA MPL (1.0ml) 18200SU Biological: Grass MATA (0.5ml) 5100SU||Phase 2|
This study will be conducted outside the grass pollen season and is comprised of five periods.
- Period 1: Screening visit
- Period 2: Eligibility and baseline symptom assessments in the mobile environmental exposure chamber (mEEC™)
- Period 3: Six treatment visits, during which the study drug will be injected
- Period 4: Post-treatment efficacy assessments in the mEEC™
- Period 5: Safety follow-up
Period 1 is the screening visit (Visit 1), and will occur 3 to 28 days before Visit 2.
Period 2 includes the pre-randomization, grass pollen exposure visits, which consist of four 3 hour sessions in the mEEC™ (Visits 2, 3, 4 and 5) during which patients will be exposed to grass pollen and record nasal and non nasal symptoms using electronic diaries (electronic Patient Data Acquisition Tablet: ePDAT™) prior to entry and every 30 minutes post entry into the mEEC™. Patients will attend mEEC™ visits on consecutive days. To be eligible for randomization and proceed to Treatment (Period 3), patients must achieve the following by the final pre treatment mEEC™ (Visit 5):
- Minimum qualifying Total Symptom Score (TSS) of at least 12 out of a possible 24 on at least one exposure using ePDAT™
- Total Nasal Symptom Score (TNSS) of at least 7 out of a possible 12 using ePDAT™
- Runny nose score of at least 2 out of 3 on at least two time points.
Period 3 includes the six treatment visits (Visit 6, 7, 8, 9, 10 and 11). After each injection, patients will be kept under observation by personnel qualified to manage systemic allergic reactions at the site for at least 30 minutes. This period can be extended by the investigator in response to injection site or systemic allergic reactions. The observation will be followed up by a telephone call approximately 24 hours later.
Period 4 consists of four 3 hour sessions (Visits 12, 13, 14 and 15) in the mEEC™ during which patients will be exposed to grass pollen and record post-treatment TSSs using the ePDAT™ as in Period 2.
Period 5 consists of an End of Study (EOS) safety follow-up visit (Visit 16) between 2 and 14 days after the last EEC visit. A telephone follow-up will be made at approximately 3, 6, and 12 months following the last injection with detailed enquiry with regard to expected and non-expected AEs, with special attention to New Onset Autoimmune Disorders (NOAD) and Neuro-inflammatory (NI) disease. For subjects who withdraw early, similar follow up will be done at approximately 1, 3, 6, and 12 months following the last injection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind Randomized Parallel Group Study of Three Cumulative Doses of Grass MATA MPL Compared to Placebo and Grass MATA in Patients With Seasonal Allergic Rhinoconjunctivitis Exposed to Grass Pollen in Mobile Environmental Exposure Chambers (mEECs™) Out of the Grass Pollen Season|
|Actual Study Start Date :||November 7, 2015|
|Actual Primary Completion Date :||May 5, 2016|
|Actual Study Completion Date :||April 28, 2017|
Placebo Comparator: Placebo (0.5ml)
Six 0.5ml injections of placebo consisting of L-Tyrosine, Ph. Eur 2%
Biological: Placebo (0.5ml)
Placebo Comparator: Placebo (1.0ml)
Six 1.0ml injections of placebo consisting of L-Tyrosine, Ph. Eur 2%
Biological: Placebo (1.0ml)
Experimental: Grass MATA MPL (0.5ml) 5100SU
Six 0.5 mL injections sequentially of placebo, placebo, 300, 800, 2000 and 2000 SU of Grass MATA with 50 µg/0.5 mL of MPL® adjuvant adsorbed to L tyrosine (2%) and 0.5% phenol (cumulative dose 5100SU).
Biological: Grass MATA MPL (0.5ml) 5100SU
Experimental: Grass MATA MPL (1.0ml) 10200SU
Six 1.0 mL injections sequentially of placebo, placebo, 600, 1600, 4000 and 4000 SU of Grass MATA per 1.0 mL and 50 µg/1.0 mL of MPL® adjuvant adsorbed to L tyrosine (2%) and 0.5% phenol (cumulative dose 10200 SU).
Biological: Grass MATA MPL (1.0ml) 10200SU
Experimental: Grass MATA MPL (1.0ml) 18200SU
Six 1.0 mL injections sequentially of placebo, 600, 1600, 4000, 4000, 4000 and 4000 SU of Grass MATA per 1.0 mL and 50 µg/1.0 mL of MPL® adjuvant adsorbed to L tyrosine (2%) and 0.5% phenol (cumulative dose 18200 SU).
Biological: Grass MATA MPL (1.0ml) 18200SU
Active Comparator: Grass MATA (0.5ml) 5100SU
Six 0.5ml injections sequentially of placebo, placebo, 300, 800, 2000 and 2000 SU of Grass MATA adsorbed to L tyrosine (2%) and 0.5% phenol (cumulative dose 5100SU).
Biological: Grass MATA (0.5ml) 5100SU
- Post-treatment TSS [ Time Frame: 21-28 days after the last injection ]The primary efficacy endpoint will be the mean average of the last three TSS measurements recorded in each of the four post-treatment Visits 12 15. TSS will be measured during the four post-treatment mEEC™ sessions conducted on consecutive days 12-15, and is defined as the sum of individual NSS (rhinorrhea, congestion, sneezing and itchiness) and NNSS (itchy/gritty eyes, tearing/watery eyes, red/burning eyes and ear/palate itching).
- Frequency of local adverse events (AEs) [ Time Frame: A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection. ]A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection.
- Frequency of systemic adverse events (AEs) [ Time Frame: 24 hours following each injection ]A Systemic AE is allergic signs and symptoms (e.g., conjunctivitis, rhinitis, cough and generalized urticaria including anaphylaxis) associated with the injection of study medication, occurring within 24 hours after the injection.
- Frequency of other AEs [ Time Frame: Up to 1 year following injections ]All post-treatment AEs that do not fall into local or systemic AEs
- Frequency of AEs of special interest (AESI) [ Time Frame: Up to 1 year following injections ]AESI includes New Onset Autoimmune Disorders and Neuro-inflammatory events.
- Safety laboratory values [ Time Frame: Up to 12 weeks ]Change in serum chemistry and haematology from baseline to Visit 16
- Specific IgE [ Time Frame: Up to 12 weeks ]Change in grass specific IgE from baseline to Visit 16
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582073
|United States, New Jersey|
|Inflamax Research Inc.|
|Neptune, New Jersey, United States, 07753|
|Study Director:||Tim Higenbottam, DSc, MD, FRCP, FFPM||Allergy Therapeutics|